FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE MRI SURESCAN
MDR report key: 8724920
·
Received June 21, 2019
Report
- Report Number
- 2649622-2019-10693
- Event Type
- Injury
- Date Received
- June 21, 2019
- Date of Event
- May 27, 2019
- Report Date
- June 24, 2019
- Manufacturer
- MPRI
- Product Code
- NVY
- UDI-DI
- 00643169309722
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN ALERT FOR OUT OF RANGE, HIGH RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THE RV LEAD WAS PROGRAMMED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517207 | SPRINT QUATTRO SECURE MRI SURESCAN | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 | 00643169309722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |